STAT

MAY 1, 2024

Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday. The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.

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PharmaVoice

MAY 1, 2024

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

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STAT

MAY 1, 2024

Pandemics start slowly — a few cases here, a few there — until suddenly people are sick or dying everywhere. Early detection by monitoring wastewater can help short-circuit that cycle. It’s difficult to tell what is happening right now with highly pathogenic avian influenza A H5N1 (bird flu), which is rapidly spreading among cows and other mammals.

Hospitals 363

Hospitals 363

Pharmaceutical Technology

MAY 1, 2024

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

Vaccines 145

Vaccines 145

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

MAY 1, 2024

NEW YORK — By the time Peter Bauman considered deep brain stimulation, he was desperate. Early onset Parkinson’s disease, diagnosed at age 49, had disabled him, ended his bartending career, and led him to consider suicide. He hoped that the treatment, known as DBS, in which an electrode connected to an external battery is inserted into the brain and emits electrical impulses, would ease his Parkinson’s tremors.

Documentation 363

Documentation Nursing Homes 363

pharmaphorum

MAY 1, 2024

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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pharmaphorum

MAY 1, 2024

Explore the challenges in weight loss treatments despite the billions spent on clinical trials for weight loss drugs. Discover why capacity remains a critical issue in the industry.

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STAT

MAY 1, 2024

I am not writing here to talk about my husband, Chadwick Boseman, who died far too young from colorectal cancer. I am not here to give any glimpses into our obviously private life and his obviously private battle with this cancer, which is affecting far more young lives than it should. The legacy he created is not about cancer and I hope you don’t remember him that way.

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BioPharma Dive

MAY 1, 2024

Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.

Vaccines 112

Vaccines 112

STAT

MAY 1, 2024

Three years ago, Moderna, flush with cash from Covid vaccine sales, announced it would start investing in the burgeoning field of gene editing. It created a new division called Moderna Genomics and struck a collaboration with Metagenomi, a University of California-Berkeley spinout that specializes in developing new gene-editing enzymes. “This will be a completely new approach for Moderna and a dramatic expansion of our modality strategy,” Moderna president Stephen Hogue told invest

Vaccines 328

Vaccines 328

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Pharmacy Management

BioPharma Dive

MAY 1, 2024

The move broadens the antitrust regulator’s campaign against allegedly “improper or inaccurate” patent listings by drugmakers to include top-selling medicines for weight loss, diabetes, asthma and COPD.

Diabetes 109

Diabetes 109

STAT

MAY 1, 2024

WASHINGTON  — The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. The DEA dictates the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, such as morphine and other injectable opioids that hospitals regularly use.

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Controlled Substances Hospitals 336

BioPharma Dive

MAY 1, 2024

Sales of the transthyretin amyloidosis treatment widely beat Wall Street forecasts in the first quarter. The company aims to extend its patent exclusivity.

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STAT

MAY 1, 2024

Blood vessels in the legs or heart sustain considerable damage when they are narrowed by poor circulation from diabetes or blocked in a heart attack. To repair them, researchers have tried using grafts from other blood vessels or giving growth factors to stimulate new tissue, but those solutions often fall short. Scientists from Boston Children’s Hospital report Wednesday in Nature that they managed to boost blood vessel growth by enlisting mitochondria, organelles that power the cell, to

Diabetes 337

Diabetes Hospitals 337

pharmaphorum

MAY 1, 2024

The MHRA's regulatory sandbox for artificial intelligence as medical device technologies, AI-Airlock, will go live this spring, according to a new strategy document

Documentation 107

Documentation 107

STAT

MAY 1, 2024

After years on the rise, the U.S. maternal mortality rate decreased in 2022, new government data show. But maternal health experts warn there’s no reason to celebrate: The dip is a course correction following the Covid-19 pandemic, and mothers in the United States continue to die at dramatically higher rates than mothers in other high-income countries.

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pharmaphorum

MAY 1, 2024

FTC sends more warnings to pharma companies over 'junk' patents to protect drugs from generic competition, including Novo Nordisk's Ozempic.

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STAT

MAY 1, 2024

CVS Health got walloped at the outset of 2024 as older adults in its Medicare plans continue to get a lot more medical care than the company expected. CVS’ operating income fell by 34% — roughly $1.2 billion — in the first quarter compared with the prior-year period, according to results released Tuesday. The company, which absorbed the health insurer Aetna in 2018, marketed its Medicare Advantage plans aggressively last year and expanded its geographic reach more than any i

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pharmaphorum

MAY 1, 2024

Polish drug delivery company Biotts says it has demonstrated delivery of insulin across the skin for the first time without the use of an injection system.

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STAT

MAY 1, 2024

Health care providers are in an acute financial situation. Record-high wages required to attract and retain talent coupled with price inflation not seen since the early 1980s are driving higher costs, while reimbursement and federal policies limit providers’ ability to cover expenses. Adding to this budgetary stranglehold are payment delays and insurance claim denials by payers, which compromise patients’ access to health care and providers’ financial viability.

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Med Ed 101

MAY 1, 2024

Depression is one of the top three health disorders in adults ages 18-34 with approximately 21.3% of these adults having depression. This means that many women suffer from depression during their peak childbearing years and will begin medication to treat it. Uncontrolled depression or anxiety may lead to issues in pregnancy. Thus, there is always […] The post SSRIs In Pregnancy appeared first on Med Ed 101.

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STAT

MAY 1, 2024

LONDON — In 2021, a team of Italian researchers reported that an experimental gene therapy they had developed seemed to be correcting the metabolic issues at the core of a rare genetic disease that left children unable to break down sugar molecules. There remained an open question, however, about whether the therapy could address a particularly debilitating manifestation of the disease, the severe skeletal deformities it caused.

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Drug Development 294

pharmaphorum

MAY 1, 2024

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

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STAT

MAY 1, 2024

Joel Zivot is a practicing clinician and associate professor of anesthesiology and surgery. He is also an advocate against the use of medicine in capital punishment. Back in February, Zivot wrote a First Opinion essay shortly after Kenneth Smith was executed using nitrogen gas in Alabama. In “ A new Louisiana capital-punishment bill would fundamentally alter physician licensing ,” Zivot argues against proposed bills in both Kansas and Louisiana that would allow “death by hyp

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Outsourcing Pharma

MAY 1, 2024

RenÃe Aguiar-Lucander, CEO of Calliditas, is driving the advancement and launch of TARPEYO â the companyâs medication targeting rare disease IgA nephropathy. We spoke with RenÃe about her journey from investment banking to science and the joy of bringing therapies to patients.

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STAT

MAY 1, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, I highly recommend reading  this investigation  STAT published today on a research project at Mount Sinai in which doctors have been taking biopsies of living patients’ brains, sparking alarm at the FDA.

Drug Pricing 276

Drug Pricing Drug Development 276

Pharma Times

MAY 1, 2024

Bladder cancer, including papillary tumours, is the ninth most common cancer type worldwide

Hospitals 120

Hospitals 120

STAT

MAY 1, 2024

As part of its reporting on Mount Sinai and the Living Brain Project, STAT sent a list of written questions to Mount Sinai. Below is a copy of the questions and responses. Can you describe for us what the Living Brain Project has accomplished, to date, and what promise the investigators feel it holds for future brain research? The Living Brian Project (LBP) is a unique study of the human brain that is characterizing each individual in a large cohort using all the tools that are currently availab

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Hospitals 275

Pharma Times

MAY 1, 2024

The progressive neurological condition affects more than six million people worldwide

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STAT

MAY 1, 2024

It’s widely known that exercise is beneficial for health. Yet science doesn’t have a clear understanding of what makes moving so good for us, including what molecular mechanisms are activated by exercise. To answer those questions, researchers launched a large, 10-year study in 2015 to understand the biological impact of physical activity in both rats and humans.

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European Pharmaceutical Review

MAY 1, 2024

A new state-of-the-art research and laboratory building is being built on AbbVie’s main campus at its Rhineland-Palatinate site, the company ’s second largest research and development ( R&D ) location globally. The central research building LUdwighafens neue Arbeitswelt (LUnA) will benefit from an investment of approximately €150 million. Currently, the Rhineland-Palatinate site has over 2,000 employees, and LUnA will house over 300 researchers and scientists, according to AbbVie.

Pharmaceutical Manufacturing 87

Pharmaceutical Manufacturing 87

pharmaphorum

MAY 1, 2024

GSK's recovery gathers pace, with a strong Q1 prompting a rise in sales and earnings forecasts for the full-year.

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European Pharmaceutical Review

MAY 1, 2024

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intell

Vaccines 87

Vaccines 87

Pharmaceutical Technology

MAY 1, 2024

Eli Lilly has announced that its net income rose to $2.24bn in Q1 2024, a 67% increase from $1.34bn in the same period of 2023.

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The Pharmacist

MAY 1, 2024

Data from large pharmacy multiples suggests that pharmacists are ‘closely following’ Pharmacy First clinical guidance for medicines, including antibiotics supply, the Company Chemists’ Association (CCA) has said. Three-quarters of consultations that passed the Pharmacy First payment gateway in the first month of the service resulted in a medicine supply, the CCA said.

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